Actos & Bladder Cancer

Last week, the pharmaceutical company, Takeda, was ordered to pay $1.3 million in punitive damages to a former Philadelphia schoolteacher who “argued the drugmaker’s Actos diabetes medicine caused his bladder cancer”, Japan Times writes.

Only a few days earlier, that man was awarded over $2.3 million in compensatory damages.

According to that Japan Times article, this was the “fifth Actos patient to convince a jury that Takeda’s former top-selling drug causes bladder cancer. Last year, a federal jury in Louisiana ordered Takeda and Eli Lilly & Co., which at one time sold Actos in the U.S., to pay $9 billion in punitive damages to a shopkeeper who blamed his cancer on the drug. That award was cut to $36.8 million.”

So far, over 8,000 Actos lawsuits have been filed in the United States over the drug’s alleged undisclosed connection with increased risk for bladder cancer, and many of those cases have been consolidated before federal courts.

JT: “Takeda argued in court filings the company properly vetted the drug and included all required warnings on its safety label. It has battled former users’ claims in trials across the country starting in 2013.”

Bloomberg News explains that the Philadelphia schoolteacher was compensated $300,000 for medical expenses and $2 million for pain and suffering after Takeda “failed to properly warn [his] doctors about Actos’s cancer risks.”

Of course, this is still a relatively insignificant company for the largest drug company in Asia, generating $16 billion in revenue since the 1999 Actos release.

Bloomberg: “The Pennsylvania case is Kristufek v. Takeda Pharmaceuticals America Inc., Philadelphia Court of Common Pleas. The consolidated Actos case in Louisiana is In Re Actos (Pioglitazone) Products Liability Litigation, 11-md-02299, U.S. District Court, Western District of Louisiana (Lafayette).”

The authors state “All therapeutic choices need to be based on the balance of potential risks and benefits. Treatment decisions are not always easy, and are best achieved when considering all available evidence. Busy clinicians may be aided in this process by syntheses of the evidence, particularly when it is rapidly evolving. A case in point is the role glucose-lowering therapies may play in modulating the elevated risk of many cancers in patients with type 2 diabetes mellitus. In this issue of Diabetes Research and Clinical Practice, Zhu et al. 1 contribute a meta-analysis of the use of pioglitazone and the risk of bladder cancer, synthesizing data from 5 previously published studies and almost 2.4 million people. From these data, they report that pioglitazone use is associated with an overall 17% increased risk of bladder cancer. The authors also summarized findings of greater risks with larger cumulative doses and longer duration of pioglitazone use, which strengthen an inference of causality for this association.”

Though Johnson et al. (2012) point out a few limitations of the above-described Zhu et al. study, the team writes “Regardless of methodologic differences, however, our conclusions are consistent, that exposure to pioglitazone is associated with an increased risk of bladder cancer in people with type 2 diabetes, compared to not being exposed to pioglitazone. This finding is further corroborated by a meta-analysis of randomized controlled trials on file with the manufacturer 3.”

They continue “With the strong and consistent evidence, including preclinical animal studies, synthesis of data from [randomized control trials] and observational studies, and demonstration of a dose-risk gradient, it seems very likely that bladder cancer is a real risk with pioglitazone for patients with type 2 diabetes. This risk is likely in the range of a 20–25% relative increase, which may be even greater with longer term use.”

For a free, no-obligation case consultation, contact our team of Actos bladder cancer lawyers at the information provided below. We have the compassion, resources, and experience required to win the justice you deserve. Call today and see how we can help.

In 2012, an article was published in Urology titled “Association between pioglitazone and urothelial bladder cancer.” by Y. Barbalat et al. that aimed to “present the current literature reporting the association between pioglitazone and bladder cancer.” To be clear, “pioglitazone” is the chemical name for the diabetes drug, Actos, manufactured by Takeda Pharmaceutical Co. and Eli Lilly & Co.

The team writes “The U.S. Food and Drug Administration (FDA) has recently informed the public that the use of pioglitazone may be associated with an increased risk of bladder cancer. 3 The European Medicines Agency (EMA) released a similar statement 4 and some European countries, such as France and Germany, have already removed pioglitazone from the market. Clearly, this association has many implications from an oncologic and clinical standpoint.”

One study the team cites was conducted by Suzuki et al., finding “pioglitazone produced calcium-containing urinary solids, which were associated with increased urothelial cytotoxicity, necrosis, and regenerative proliferation.” Another study cited found “pioglitazone is a PPARγ ligand used in the treatment of DMII and was found to have carcinogenic activity toward the male rat bladder.”

Concerning human subjects trials, the paper notes first a study evaluating 5,238 patients receiving Actos that found “trend toward more bladder tumors” but failed to reach statistical significance. Another study evaluating over 30 thousand Actos users of 193 thousand members of a particular health insurance plan found “Among men only, there was a significant increase in the relative hazard of bladder cancer with >24 months of exposure (HR 1.6; 95% CI 1.2-2.3) and with a >28,000 mg cumulative dose (HR 1.8; 95% CI 1.2-2.6).” That means that in men who used Actos for longer than two years, the risk for bladder cancer was raised by 60%, and in men who took more than 28,000 mg of Actos over time, the risk for bladder cancer was raised by 80%, nearly double the risk for bladder cancer compared with non-users.

Overall, and thankfully, the team notes that “Ninety-five percent of cancers diagnosed among pioglitazone users were detected at an early stage” and comments that “the health benefits of pioglitazone may outweigh the risk of bladder cancer associated with this drug. Nevertheless, urologists should be aware of this possible risk, especially when managing diabetic patients with hematuria or other risk factors for bladder cancer.”

Due to the fact that a number of people have used Actos unaware of the connection the drug has with bladder cancer, a number of Actos bladder cancer lawsuits have been filed. If you or a loved one used Actos and suffered bladder cancer as a result, you too may be entitled to significant financial compensation. For a free, no-obligation case consultation, contact our team of Actos lawyers at the information provided below. We have the experience, resources, and skills required to win the justice you deserve. Call today and see how we can help.

This team of researchers wrote “The objective of this nationwide case-control study was to evaluate the risk of specific malignancy in diabetic patients who received thiazolidinediones (TZDs)” and studied a total of 606,583 patients with type II diabetes without a history of cancer.

“A total of 10,741 liver cancer cases, 7,200 colorectal cancer cases, and 70,559 diabetic controls were included. A significantly lower risk of liver cancer incidence was found for any use of rosiglitazone (OR: 0.73, 95% CI: 0.65-0.81) or pioglitazone (OR: 0.83, 95% CI: 0.72-0.95), respectively.” This means that Actos (pioglitazone) was associated with a lower risk for liver cancer, and so was Avandia (rosiglitazone).

However, the team found that “a potential increased risk for bladder cancer with pioglitazone use 3 years could not be excluded (OR: 1.56; 95% CI: 0.51-4.74),” meaning that Actos was associated with a 56% increased risk for bladder cancer.

Due to the fact that a number of people have used Actos unaware of the risk for bladder cancer, a number of Actos bladder cancer lawsuits have been filed. If you or a loved one used Actos and suffered bladder cancer, contact our team of Actos bladder cancer lawyers for a free consultation at the information provided below. You and your family may be entitled to significant financial compensation, and we have the experience, resources, and skills required to win the justice you deserve.

Recently, a federal court has ordered that the manufacturers of the diabetes drug Actos (pioglitazone hydrochloride, by Takeda Pharmaceutical Co. and Eli Lilly & Co.) pay $9 billion in damages when it was determined that these companies failed to warn the public of cancer risks associated with their medication.

Though some legal experts believe that this penalty will be lowered by appellate courts, this federal decision marks a turning point in a years-long struggle for compensation for damages caused by Actos. (Reuters notes that “The $9 billion in punitive damages awarded by the jury against Takeda and Eli Lilly exceed the $5 billion penalty that a jury in Alaska imposed on Exxon Mobil Corp for the Exxon Valdez oil spill in 1989.”)

For years, law firms around the country have been signing up clients injured by Actos to secure compensation from a settlement such as this, and it seems that day has come a bit closer.

Unfortunately, Actos manufacturers continued producing the drug in light of a huge number of scientific studies connecting Actos to cancer and liver damage without warning patients, and as such, the number of patients injured by the drug has likely increased rather than decreased while the scientific community concluded the drug is unacceptably dangerous.

Here are a few studies I’ve summarized linking Actos and bladder cancer:

If you or a loved one used Actos and suffered bladder cancer as a result, you may be entitled to significant financial compensation. For a free, no-obligation case consultation, contact our team of Actos bladder cancer lawyers at the information provided below. We have the experience, resources, and skills required to win the justice you deserve. Call today and see how we can help.

In 2011, Robert Elford Ryder published a report in the medical journal The Lancet titled “Pioglitazone and bladder cancer” which discusses the link between diabetes drug Actos (Tadeka Pharmaceuticals, Inc.) and bladder cancer.

At the outset of his piece, Ryder states “In June, 2011, the French and German regulatory bodies suspended pioglitazone over the risk of bladder cancer.” However, because he states diabetes is a disease characterized by premature death due to diminished cardiovascular capacity, and that there is evidence to believe Actos staves off diminishing cardiovascular capacity, people should continue using Actos despite the risk for bladder cancer.

I thought this logic was a little fishy, since if patients use Actos and it does indeed indirectly protect from heart attack or stroke, then patients would live long enough to get bladder cancer. Of course, it seems like without Actos patients face increased risk for heart attack and stroke, making this appear as a catch-22. Thankfully, it isn’t: there are number of other effective diabetes drugs that do not carry the risk for bladder cancer as Actos does.

Why there isn’t mention of other effective diabetes drugs in his piece, and why Ryder advocates the use of Actos in the face of increased risk for cancer became obvious upon reading the final line: “I have previously received educational sponsorship, speaker fees, and consultancy fees from several pharmaceutical companies including Eli Lilly, GlaxoSmithKline, Novo Nordisk, Sanofi-Aventis, and Takeda.”

No wonder Ryder advocates for the use of Actos: he works for the manufacturer.

In 2013, a team of researchers led by MT Bazelier published a paper titled “Use of thiazolidinediones and risk of bladder cancer: disease or drugs?”, where it is stated “Pioglitazone, a drug for the treatment of type 2 diabetes mellitus has been associated with bladder cancer in observational studies” but that “Diabetes mellitus itself has also been linked with bladder cancer.” So, the aim of this study was “to estimate the risk of bladder cancer for diabetic patients using thialozidinediones (TZDs) compared with patients in other treatment stages of the disease.”

Studying 179,056 antidiabetic drug users compared with three-times as many controls, essentially, what the team found was that “Compared with non-diabetic controls, patients using antidiabetic medication experienced a 1.3-fold increased risk of bladder cancer”. That is, antidiabetic drug use raised the risk for bladder cancer by about 30%. Insulin therapy caused a 40% increase in risk for bladder cancer, while Avandia use only raised the risk by 20%. The risk for bladder cancer with the use of thiazolidinediones (a class of drugs including Actos) raised the risk for bladder cancer by 30%.

Concluding that “The association between TZD use and bladder cancer is probably confounded by the underlying disease”, we see that this team did not decisively determine that it was drugs or disease that caused the increased risk for bladder cancer in this cohort. It is important to note, however, that many other contemporary studies have in fact concluded that Actos specifically and dramatically raises the risk for bladder cancer among diabetic patients.

As a result of this, coupled with a failure to warn by the manufacturer of Actos, a number of Actos bladder cancer lawsuits have been filed. If you or a loved one used Actos and suffered bladder cancer, you too may be entitled to significant financial compensation for your undue injury.

For a free, no-obligation case consultation, contact our team of Actos bladder cancer lawyers at the information provided below. We have the compassion, resources, and experience required to win the justice you deserve. Call today and see how we can help.

In 2014, a team of researchers led by SM Jin published the results of a study that aimed to determined if low doses of pioglitazone (Actos) also raised the risk for bladder cancer among diabetic patients. It has already been demonstrated by many other studies that long-term and high-dose Actos therapy dramatically raises the risk for bladder cancer.

Among the control patients, there were 237 cases of bladder cancer identified, and among Actos patients, there were 30 cases of bladder cancer identified. Using statistics, the team found that these Actos patients who, we should be sure to note, were using only 15mg/day of the drug, were about 14% more likely to develop bladder cancer than patients who had never used the drug.

Due to the fact that the manufacturer of Actos has failed time and again to warn users of the increased risk for bladder cancer associated with their product, a number of Actos bladder cancer lawsuits have been filed. If you or a loved one used Actos and suffered bladder cancer, you too may be entitled to significant financial compensation for your injury.

For a free, no-obligation case consultation, contact our team of Actos bladder cancer lawyers at the information provided below. We have the experience, resources, and skills required to win the compensation you deserve. Call today and see how we can help.

As such, the study team writes, “The use of pioglitazone, a thiazolidinedione (TZD), may increase the risk of bladder cancer in patients with type 2 diabetes. In this study, we assessed the risk of bladder cancer associated with the use of TZDs and between pioglitazone and rosiglitazone, an alternative TZD.”

This team studied people who used TZDs (18,459) and compared health outcomes with patients who used sulfonylurea (41,396) in the treatment of type-II diabetes. Describing results, the team states “We identified 60 incident bladder cancers in the TZD cohort and 137 cancers in the SU cohort” and “the risk of bladder cancer was increased among patients with the longest duration of TZD vs SU therapy”. That is, bladder cancer was identified among both groups, but that long duration TZD use gave more bladder cancer than SU. “Risk of bladder cancer also increased with increasing time since initiation of [Actos] and [Avandia]”.

Due to the act that many people used Actos unaware of the risk for bladder cancer associated, a number of Actos bladder cancer lawsuits have been filed. If you or a loved one used Actos and suffered bladder cancer, you too may be entitled to significant financial compensation. For a free, no-obligation case consultation, contact our team of Actos bladder cancer lawyers at the information provided below. We have the compassion, resources, and experience required to win the justice you deserve.

To obtain data for this study, the authors write “Case/noncase bladder cancer reports associated with antidiabetic drug use were retrieved from the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (AERS) between 2004 and 2009 and analyzed by the reporting odds ratio (ROR).”

Results showed that “Ninety-three reports of bladder cancer were retrieved, corresponding to 138 drug-reaction pairs (pioglitazone, 31; insulin, 29; metformin, 25; glimepiride, 13; exenatide, 8; others, 22)” and the relative risk found “was indicative of a definite risk for pioglitazone (4.30 [95% CI 2.82-6.52]), and a much weaker risk for gliclazide and acarbose, with very few cases being treated with these two drugs (6 and 4, respectively).”

That is, this study found that use of pioglitazone (Actos) raises the risk for bladder by 430% compared to non-users. Due to the fact that the manufacturer of Actos has failed time and again to adequately warn users of the risk for bladder cancer, a number of Actos bladder cancer lawsuits have been filed.

If you or a loved one used Actos and suffered bladder cancer as a result, you too may be entitled to significant financial compensation. For a free, no-obligation case consultation, contact our team of Actos bladder cancer lawyers at the information provided below. We have the compassion, experience, and resources required to win the justice you deserve.

About this Blog

This blog chronicles legal and scientific news relating to personal injuries caused by defective drugs and medical devices. It is published by injury lawyer Justinian C. Lane, an attorney who takes a personal interest in each of his clients’ cases.